文件控制程序-中英文對(duì)照

TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DocumentNo.:DC20001Rev.No.:A00PagePAGE1ofNUMPAGES13(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)RevisionHistoryREVDCN#INITIATEDBYEFFECTIVEDATE(MM/DD/YY)DESCRIPTIONA00D141601WilliamMagramo04/18/14InitialReleaseApprovedDCNonFileinDocumentControlAPPROVEDBYMotoakiWakuiAUTHORIZEDBYSKLamCONFIDENTIALPROPERTYOFZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDThisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorimpliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentofZhongshanSunmingOpticalTechnologiesLimited.?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDALLRIGHTSRESERVEDTITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DOC.NO.DC20001REVISIONA00PAGEPAGE2OFNUMPAGES13?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)PURPOSE目的Todefineaprocedureforthegeneration,revision,handling,approval,retention,storageofinternaldocumentsaswellascontrolofexternaldocuments.為內(nèi)部文件的生成，修改，處理，批準(zhǔn)，保留，保存以及對(duì)外部文件的控制定義程序。SCOPE范圍Thisprocedureisapplicabletoqualitymanagementsystem(QMS)documentationsuchassystemmanual,procedures&workinstructions.本程序適用于質(zhì)量管理體系（QMS）的系統(tǒng)文件，如體系手冊(cè)，程序文件及作業(yè)指導(dǎo)書。ThisprocedurealsocoverstheDCN&ECNgenerationandapprovalsignatoryforQMSdocumentationandproductdocumentations.本程序還包括質(zhì)量管理體系文件和產(chǎn)品文件的文件變更通知（DCN）&工程變更通知（ECN）的生成和審批簽署。Thisprocedurealsocoverscontrolandhandlingofcustomerdocumentsandotherregulatoryrequirements.本程序還包括客戶文件和其他法規(guī)要求的控制和處理。Thisprocedurealsocoverscontrolandhandlingofsupplierdocuments.本程序還包括對(duì)供應(yīng)商文件的控制和處理。DEFINITIONS&ABBREVIATIONS術(shù)語(yǔ)與定義QualityManagementSystem(QMS)Documentation-referstoadocumentcategorycomprisingofSystemManual,ProcedureandWorkInstruction.質(zhì)量管理體系（QMS）文件-指的是由體系手冊(cè)，程序文件和作業(yè)指導(dǎo)書組成的文件類。ProductDocumentation-referstoadocumentcategorycomprisingofBOM,ProductDrawings,ProductSpecificationsandProductManufacturingProcedure.產(chǎn)品文件-指的是由BOM，產(chǎn)品圖紙，產(chǎn)品規(guī)格書，產(chǎn)品制造程序組成的文件類。SystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.體系手冊(cè)-描述適用于SUNMING的政策，程序和實(shí)踐，實(shí)現(xiàn)產(chǎn)品和服務(wù)質(zhì)量的文件。體系手冊(cè)歸類為1級(jí)文件。Procedure-asetoflogicalstepsinwhichweperformplannedtaskorexecuteaprocess.Itmaybeageneraldescriptionofactivitiessupportingthesystemmanual.AprocedureisclassifiedasLevel2document.程序–一套我們執(zhí)行計(jì)劃或執(zhí)行任務(wù)的過(guò)程中合乎邏輯的步驟。它可以是支持體系手冊(cè)活動(dòng)的一個(gè)概括的描述。程序歸類為2級(jí)文件。WorkInstruction(WI)-acollectionofdetailedstatement,includingillustrationsonhowtoperformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3document.作業(yè)指導(dǎo)書（WI）-詳細(xì)陳述的匯集，包括在某一過(guò)程或活動(dòng)中如何執(zhí)行某個(gè)步驟的說(shuō)明。作業(yè)指導(dǎo)書歸類為3級(jí)文件。DocumentChangeNotice(DCN)–isusedtoinitiate,reviseortoobsoleteanexistingQMSdocument(SystemManual,Procedure,WorkInstruction).文件變更通知（DCN）-是用來(lái)發(fā)起，修改或廢止現(xiàn)有的質(zhì)量管理體系文件（體系手冊(cè)，程序文件，作業(yè)指導(dǎo)書）。EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程變更通知（ECN）-是用來(lái)發(fā)起，修改或廢止現(xiàn)有的產(chǎn)品文件。ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementRepresentative.ISO管理代表-QA經(jīng)理為指定的ISO管理代表Purpose-brieflystatesthedocument’sintendeduse/s.目的-簡(jiǎn)要陳述文件的使用意圖。Scope-brieflystatesthedocument’scoverageorextentofuse.范圍-簡(jiǎn)要陳述文件的使用范圍或程度。Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定義與術(shù)語(yǔ)-定義正文中使用的術(shù)語(yǔ)，以便使用者在此基礎(chǔ)上更容易理解。AssociatedDocuments-listofotherdocumentsreferencedandothersupportingworkinstructions.相關(guān)文件-列出引用的其他文件和其他輔助作業(yè)指導(dǎo)書。GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystepinstruction一般要求-程序本身或詳細(xì)內(nèi)容;逐步說(shuō)明。ApprovalSignaturelistabbreviations:批準(zhǔn)簽名名單縮寫CEO -ChiefExecutiveOfficer首席執(zhí)行官VPS -VPofSales銷售副總VPM -VPofGlobalMarketing全球市場(chǎng)副總DFA-DirectorofFailureAnalysis技術(shù)支援總監(jiān)DQA -DirectorofQuality質(zhì)量總監(jiān)DOP -DirectorofProduction生產(chǎn)總監(jiān)MAC -ManagerofAccounts財(cái)會(huì)經(jīng)理MPR -ManagerofPurchasing采購(gòu)經(jīng)理MQA -ManagerofQualityAssuranceQA經(jīng)理MHR -ManagerofAdmin/HumanResources行政與人力資源經(jīng)理MME-ManagerofAdvancedManufacturingEngineering高級(jí)制造經(jīng)理MCR-ManagerofCleanRoom凈化間經(jīng)理ASSOCIATEDDOCUMENTS相關(guān)文件DC30001 :WorkInstructionforDocumentNumbering文件編號(hào)作業(yè)指導(dǎo)書DC30002 :WorkInstructionforDocumentChangeNotice(DCN)Generation文件變更通知生成作業(yè)指導(dǎo)書DC30003 :WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程變更通知生成作業(yè)指導(dǎo)書DC30004 :WorkInstructionforReleasingDocumentstoSuppliers發(fā)布文檔給供應(yīng)商之工作指引DC30005 :WorkInstructionforRetentionofQualityDocumentsandRecords品質(zhì)文件/記錄保存作業(yè)指導(dǎo)書GENERALREQUIREMENTS一般要求QualityManagementSystem(QMS)Documentationhierarchy品質(zhì)管理系統(tǒng)（QMS）文件等級(jí)Level等級(jí)Classification分類1SystemManual體系手冊(cè)2Procedure程序文件3WorkInstruction作業(yè)指導(dǎo)書4Forms&LocallyControlledDocuments表格&當(dāng)?shù)乜刂莆募﨑ocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsofnomenclatureincludingtherevisionnumbering.文控中心（DCC）應(yīng)負(fù)責(zé)文件編號(hào)的分配和控制。參考DC30001（文件編號(hào)作業(yè)指導(dǎo)書）關(guān)于命名包括版本編號(hào)的細(xì)節(jié)。Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.工作表格的樣本應(yīng)在每個(gè)文件中納入附件結(jié)合。文控中心應(yīng)根據(jù)申請(qǐng)?zhí)峁┻@些表格的電 子檔。InitialreleasedandcompletelyrewrittendocumentsshallundergoapprovaloftheISOManagementRepresentative.初期發(fā)行和重寫的文件必須經(jīng)過(guò)ISO管理代表審批。DCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.文控中心應(yīng)打印已批準(zhǔn)文件供SUNMING的職員在文件控制中心查看。Changesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallbereviewedforadequacybeforeapprovalbythefollowingsignatory:發(fā)起，修改和廢止一份文件須審查其適當(dāng)充分后由下列人員簽名批準(zhǔn)才可發(fā)行變更（通過(guò)文件變更通知&工程變更通知）。QMSDocumentCategoryCategoryCodeApprovalSignatureListGeneralManagement日常管理GMCEO/VPS/DQA/MQANewBusinessDevelopment新業(yè)務(wù)開發(fā)NBCEO/VPS/VPMProductQualification產(chǎn)品資格PQCEO/DFAHR&AdminDocuments人力資源&行政文件HRCEO/MHRDocumentControl文件控制DCCEO/DQA/MQAQualityAssurance品質(zhì)保證QACEO/DQA/MQADesignandEngineeringDocuments設(shè)計(jì)與工程文件DECEO/DFAProductionDocuments生產(chǎn)文件生產(chǎn)文件PDCEO/DOP/MQAPurchasingDocuments采購(gòu)文件PRCEO/DQA/MQADocumentcontrolstaffisresponsiblefor“routingforapproval”oftheEngineeringChangeNotice(ECN).AnormalChangeNoticeFormsshallbecompletelysignedwithin2workingdaysforECNand5workingdaysforDCNotherwisetheinitiatorshallbeinformedofthedelay.Urgent(sameday)changesshallberoutedbyinitiator.文件控制工作人員負(fù)責(zé)跟進(jìn)工程變更通知（ECN)的安排和批準(zhǔn)。正常工程變更通知（ECN)應(yīng)在2個(gè)工作日內(nèi)完成簽署以及在5個(gè)工作日內(nèi)完成DCN的簽署，若有延誤應(yīng)通知發(fā)起人。緊急的（當(dāng)天）變更，應(yīng)由發(fā)起人負(fù)責(zé)跟進(jìn)。Thefollowingformatshallbeuseasageneralguidelineingeneratingnewsystemmanuals,proceduresandworkinstructions.Aspecimenofthestandarddocumentformatisshowninattachment1&2.下面的格式應(yīng)作為生成新的體系手冊(cè)，程序文件和作業(yè)指導(dǎo)書的一項(xiàng)通用指南來(lái)使用。標(biāo)準(zhǔn)文件格式的樣本詳見附件1和2Purpose目的(ForLevel1&2only)Scope范圍Definitions&Abbreviations術(shù)語(yǔ)與定義(ForLevel1&2only)AssociatedDocuments相關(guān)文件SafetyRequirements安全要求(ForLevel3only)GeneralRequirements一般要求Procedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandeffectiveness.按照要求以及工序評(píng)審的一致性和時(shí)效性的需要來(lái)更新程序。Sales&MarketingTeamshalldeterminetheneedforreviewofcustomerdocumentswithrelevantdepartments(refertoDC30004:WorkInstructionforReceivingandControlofCustomerandOtherDocument).銷售/市場(chǎng)部和相關(guān)部門應(yīng)確定對(duì)客戶文件評(píng)估的需求（參考DC30004：客戶和其他文件的接收和管控作業(yè)指導(dǎo)書）。SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsrespectively.供應(yīng)商質(zhì)量工程師應(yīng)確定對(duì)供應(yīng)商的文件評(píng)審的需求。DCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlistwhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).文控中心應(yīng)負(fù)責(zé)質(zhì)量文件/記錄的歸檔。應(yīng)保持標(biāo)示文件位置的主列表以便查找，此要求同時(shí)適用于印刷版和電子檔。（參考DC30004：質(zhì)量文件/記錄保管作業(yè)指導(dǎo)書）。Controlleddocumentsidentification.受控文件鑒定CONTROLLED–Documentthatshallbeusedasregulatoryproceduresandworkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareofficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.規(guī)范程序和受此類文件影響范圍內(nèi)的作業(yè)指導(dǎo)書應(yīng)受控使用，該類文件的每頁(yè)應(yīng)附有CONTROLLEDCOPY標(biāo)識(shí)的紅色水印，（見附件3樣本）。保存在SUNMING內(nèi)聯(lián)網(wǎng)的質(zhì)量管理體系文件的文件夾中的網(wǎng)絡(luò)電子版本也視為受控文件。本文件在任何時(shí)候提出的正式變更都應(yīng)由文控中心自動(dòng)回收和更新。文控中心應(yīng)保持一個(gè)分發(fā)受控文件（印刷版）的記錄。AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredinkshallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.任何文件在沒有用紅墨水印的CONTROLLEDCOPY標(biāo)識(shí)默認(rèn)的情況下被視為未受控的文件，不受控的文件印發(fā)只作參考。BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanforitssolepurposeandlegitimateuse,isstrictlyprohibited.受控和未受控文件均為公司的機(jī)密文件，任何文件除了其唯一目的和合法使用以外嚴(yán)禁任何未經(jīng)授權(quán)的使用，復(fù)印，或擁有。SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceofinterpretationarise,theEnglishlanguageinterpretationshallprevail.SUNMING文件可能存在英語(yǔ)和漢語(yǔ)